Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination of low levels of albumin in urine by immunoturbidimetric assay. For in vitro diagnostic use. 4 x 20 ml., 2 x 10 ml.

Pointe Scientific, Inc. Microalbumin Reagent for the quantitative determination of low levels of albumin in urine by immunoturbidimetric assay. For in vitro diagnostic use. 4 x 20 ml., 2 x 10 ml.
Pointe Scientific, Inc. Microalbumin - M7562-100

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of microalbumin in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JIT

Device Name: Calibrator, Secondary

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: CH

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.1150

Third Party Flag: N

Medical Specialty: CH

Code: DDZ

Device Name: Albumin, Fitc, Antigen, Antiserum, Control

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 866.5040

Third Party Flag: N

Medical Specialty: IM

Device Id: 00811727011886

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A